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FDA 510(k)

KENDRO HERACELL CO2 INCUBATOR

K-Number: K002805 · 2000-11-09

ApplicantKendro Laboratory Products, L.P.
Decision Date2000-11-09
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KENDRO HERACELL CO2 INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Kendro Laboratory Products, L.P.. It received FDA 510(k) clearance on 2000-11-09 under 510(k) number K002805. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENDRO HERACELL CO2 INCUBATOR?

KENDRO HERACELL CO2 INCUBATOR is a medical device that received FDA 510(k) clearance on 2000-11-09. The listed applicant is Kendro Laboratory Products, L.P.. The 510(k) number is K002805.

When did KENDRO HERACELL CO2 INCUBATOR receive FDA 510(k) clearance?

KENDRO HERACELL CO2 INCUBATOR received FDA 510(k) clearance on 2000-11-09, under 510(k) number K002805.

Who is the listed applicant for KENDRO HERACELL CO2 INCUBATOR?

The FDA 510(k) record lists Kendro Laboratory Products, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KENDRO HERACELL CO2 INCUBATOR?

The FDA product code for KENDRO HERACELL CO2 INCUBATOR is MQG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Kendro Laboratory Products, L.P. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K023465KENDRO HERACELL 240 INCUBATOR

Related Devices (Code: MQG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261083Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)CooperSurgical, Inc.K260194Vacuum Pump (Model: AD-VPUM-500)Sheng Sheng Yi (Beijing) Technology Company LimitedK242684Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.K232493Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)Wuhan Huchuang Union Technology Co., Ltd.K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishGenea Biomedx Pty, Ltd.K173264EmbryoScope+Vitrolife A/S

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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